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Introduction and Overview
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Biosurveillance is a complex concept defined by Homeland Security Presidential Directive 21 (HSPD-21) as “active data-gathering with appropriate analysis and interpretation of biosphere data that might relate to disease activity and threats to human or animal health—whether infectious, toxic, metabolic, or otherwise, and regardless of intentional or natural origin—in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity” (White House, 2007). The biosurveillance process detects, monitors, and characterizes national security health threats, in human and animal populations, food, water, agriculture, and the environment. It involves the detection of disease outbreaks as well as the responsibility to “provide decision-makers and the public with accurate and timely information about how adverse impacts might be prevented, managed or mitigated” (Nuzzo, 2009). Many federal agencies and all 50 states are involved in biosurveillance activities, in addition to local governments and many public and private organizations. Each year, billions of dollars are spent on biosurveillance, including animal, human, and environmental surveillance, as well as health care management and technology and infrastructure maintenance, activities which have implications for biosurveillance (Wagner et al., 2006). However, despite the recognition of its importance, definitions and boundaries of biosurveillance activities (especially as they coincide with other areas of public health and security) often vary based on perspective.

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1The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.



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1 Introduction and Overview1 Biosurveillance is a complex concept defined by Homeland Security Presidential Directive 21 (HSPD-21) as “active data-gathering with ap- propriate analysis and interpretation of biosphere data that might relate to disease activity and threats to human or animal health—whether infec- tious, toxic, metabolic, or otherwise, and regardless of intentional or nat- ural origin—in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity” (White House, 2007). The biosurveillance process detects, mon- itors, and characterizes national security health threats, in human and animal populations, food, water, agriculture, and the environment. It in- volves the detection of disease outbreaks as well as the responsibility to “provide decision-makers and the public with accurate and timely infor- mation about how adverse impacts might be prevented, managed or miti- gated” (Nuzzo, 2009). Many federal agencies and all 50 states are involved in biosurveillance activities, in addition to local governments and many public and private organizations. Each year, billions of dollars are spent on biosurveillance, including animal, human, and environmental surveil- lance, as well as health care management and technology and infrastruc- ture maintenance, activities which have implications for biosurveillance (Wagner et al., 2006). However, despite the recognition of its im- portance, definitions and boundaries of biosurveillance activities (espe- cially as they coincide with other areas of public health and security) often vary based on perspective. 1 The planning committee’s role was limited to planning the workshop, and the work- shop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. 1

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2 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION Priority was placed on developing a biosurveillance strategy follow- ing the September 11, 2001, terrorist attacks on the United States and the 2001 anthrax attacks. Several activities resulted, some of which were parallel but independent of each other at different agencies, in recogni- tion of this priority. The following describes some of these activities, many of which overlap but do not necessarily align. In 2004, HSPD-9 (Defense of United States Agriculture and Food) and HSPD-10 (Biodefense for the 21st Century) charged the Secretary of Homeland Security to “integrate all federal agency efforts” and to “create a new biological threat awareness capacity” that would detect biological attacks early. In 2004, the Department of Homeland Security (DHS) cre- ated the National Biosurveillance Integration System (NBIS), which was intended to be the nation’s “first system capable of providing compre- hensive and integrated biosurveillance and situational awareness” (OIG, 2007), and designed to include a role for the pertinent federal agencies in building this integrated system. In 2007 the Implementing Recommendations of the 9/11 Commis- sion Act created the National Biosurveillance Integration Center (NBIC) within DHS to identify, integrate, and analyze data to detect biothreats and disseminate alerts. NBIC is charged with working with partner agen- cies to (1) acquire data that can be analyzed, (2) leverage expertise, (3) obtain strategic and operational guidance, and (4) maintain innovative information technologies. NBIC was established to realize the goals of NBIS and to serve as the center for information and personnel contribut- ed by NBIS partners. HSPD-21, which was released a few months after passage of the act that created NBIC, charged the U.S. Department of Health and Human Services (HHS) with establishing “an operational national epidemiologic surveillance system for human health, with international connectivity where appropriate, that is predicated on state, regional, and community- level capabilities and creates a networked system to allow for two-way information flow between and among Federal, State, and local govern- ment public health authorities and clinical health care providers.” In re- sponse to this directive, the Centers for Disease Control and Prevention (CDC) established the Biosurveillance Coordination Unit (BCU) in 2008. BCU supports the National Biosurveillance Advisory Subcommit- tee (NBAS), established in 2008 by CDC per a mandate in HSPD-21 to create an advisory body to HHS on biosurveillance matters. In 2008, BCU released the National Biosurveillance Strategy for Human Health, and it subsequently revised the strategy and released an expanded version

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3 INTRODUCTION AND OVERVIEW in 2010 (CDC, 2010). This strategy defined the scope and function of biosurveillance for human health to include • all hazards, including biological, chemical, radiological, nuclear, and explosives, both intentional and natural; • definitions established by urgency and the potential for multi- jurisdictional interest; • urgent notifiable conditions and nonspecific and novel health events; • ad hoc data gathering, analysis, and application of information; • functions including case detection, event detection, signal valida- tion, event characterization, notification and communication, and quality control and improvement; and • support for rapid and efficient discharge of responsibilities for the International Health Regulations. The strategy also named six priorities for national biosurveillance: electronic health information exchange, electronic laboratory information exchange, unstructured data, integrated biosurveillance information, global disease detection and collaboration, and the future biosurveillance workforce. STATUS OF NATIONAL BIOSURVEILLANCE INTEGRATION In the past several years, recognition has been made of the gaps and challenges in biosurveillance efforts and the integration of biosurveillance activities, and several steps to address these challenges have been taken. In 2007, DHS released a report following its auditing of the NBIS pro- gram (OIG, 2007). DHS determined that NBIS was falling short of its objectives, partly due to a lack of leadership and staff provided by DHS. Documents to guide information technology were not complete, and management communication and coordination with stakeholders and contractors were ineffective. In 2009, the NBAS recommended (1) the establishment of an inter- agency coordination committee (led by the Executive Office of the Pres- ident) to define goals and establish responsibility for a biosurveillance strategy, (2) the scope of biosurveillance to be global, (3) adequate fund-

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4 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION ing and assignment of personnel, (4) the leveraging of electronic data, and (5) investment in new technologies (NBAS, 2009). In 2011, NBAS made further recommendations to build on its 2009 recommendations in the following areas: 1. Governance: Establish federal biosurveillance oversight (reiter- ating the 2009 recommendation). 2. Information Exchange: Support the implementation of the In- ternational Health Regulations; integrate human, animal, food, vec- tor, and environmental surveillance systems; expand biosurveillance to include environmental aspects. 3. Workforce: Promote a sustainable interdisciplinary workforce with investments in expertise (especially in public health infor- matics; social and behavioral epidemiology; environmental, hu- man, and animal health; vector biology; and disaster response). 4. Research and Development: Invest in research to develop and build on innovative technologies that will enhance the efficiency and sensitivity of biosurveillance; select the best approaches and scale them (NBAS, 2011). In 2009, the Government Accountability Office (GAO) recommend- ed that NBIC define and communicate a common mission and purpose, define common procedures and strategies to align multiple agency cul- tures, and establish performance measures to monitor and evaluate the effectiveness of collaboration (GAO, 2009). The report stressed coordi- nation and integration among agencies and biosurveillance efforts. The Commission on the Prevention of Weapons of Mass Destruction Prolif- eration and Terrorism (2010) subsequently issued a report determining that the U.S. government was “failing” at protecting the United States from threats. Also in 2010, GAO made further recommendations to es- tablish a leadership mechanism with authority and accountability and to develop a national biosurveillance strategy that 1. defines the scope and purpose of a national capability; 2. provides goals, objectives and activities, priorities, milestones, and performance measures; 3. assesses the costs and benefits associated with supporting and building a national capability and identifies the resource and in- vestment needs;

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5 INTRODUCTION AND OVERVIEW 4. clarifies the roles and responsibilities of leading, partnering, and supporting a national capability; and 5. articulates how the strategy is integrated with and supports other related strategies’ goals, objectives, and activities (GAO, 2010). OVERVIEW OF THE WORKSHOP On September 8-9, 2011, the Institute of Medicine (IOM), held a workshop to explore the information-sharing and collaboration processes needed for the nation’s integrated biosurveillance strategy. As William Raub, co-chair of the planning committee for the workshop and former science advisor to the Secretary of HHS, said in his introductory re- marks, integration and communication of information “is a formidable and technical challenge. The collaboration, the sharing, and the integra- tion are difficult in the context of multiple agencies with multiple mis- sions and a rich variety of data sets, including areas where the data sets are nonexistent. . . . If it were easy, it would be done.” The goals of the workshop were to • examine the strengths and limitations of different models of in- formation analysis, control, and distribution, with a focus on identifying best practices and incentives for information sharing and exploring the options for when and what information is shared and how it is attributed and acknowledged; • consider examples and lessons learned from other similar infor- mation sharing collaborations; • explore approaches to developing an effective and sustainable concept of operations that includes joint rules, procedures, and performance measures; and • illustrate the value added in collaboration through scenarios and real-life examples. The planning committee designed the workshop to be pragmatic. Its goal was to explore concrete, near-term steps which could set the com- munity in the right direction. Raub recalled advice he once received from the renowned computer designer Wesley A. Clark, who said that plan- ning requires three things: a rough sense of where you want to be even- tually, precise knowledge of what you need to do next, and the willingness to iterate as you go forward so that you can get where you want

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6 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION to go. “Much of what motivated our design is to figure out precisely what to do next,” said Raub. ORGANIZATION OF THIS SUMMARY This summary provides a factual account of the presentations given at the workshop. Opinions expressed within this summary are not those of the Institute of Medicine, the Standing Committee, or its agents, but rather of the presenters themselves. Statements are the views of the speakers and do not reflect conclusions or recommendations of a formal- ly appointed committee. This summary was authored by a designated rapporteur based on the workshop presentations and discussions and does not represent the views of the institution, nor does it constitute a full or exhaustive overview of the field. Chapters 2, 3, and 4 of this report summarize the remarks of eight invited presenters who spoke at the workshop. Chapter 2 presents per- spectives from three government agencies: CDC, the Department of Ag- riculture, and the Department of Defense. Chapter 3 describes the presentations of three state and local public health officials from New York City, North Carolina, and Marion County, Indiana. Chapter 4 offers views from two outside observers: one a Federal Reserve official, the other a top medical official from Israel. Chapter 5 summarizes an extended panel discussion that occupied the central portion of the workshop. The discussion was organized around a fictional scenario based on a foodborne pathogen, with several moves of the scenario meant to illustrate the issues involved in coordi- nating surveillance and response. Participation by representatives from a range of federal agencies provided a rich variety of insights into both the potential and difficulties of biosurveillance. Finally, Chapter 6 describes the talks of four speakers who collec- tively proposed elements of a concept of operations (CONOPS) for biosurveillance, using NBIC as an example, as a way of moving toward a more secure nation and world. The chapter also summarizes the discus- sion at the end of the workshop.

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7 INTRODUCTION AND OVERVIEW ACKNOWLEDGMENTS The production of this summary would not be possible without the hard work and dedication of several people, and the sponsorship of the DHS’s Office of Health Affairs. The workshop was held under the auspi- ces of the Standing Committee on Health Threats Resilience, whose ex- pertise shaped the agenda, goals, and objectives. It was planned by a dedicated committee who provided hard work and effort toward execut- ing the agenda. The reviewers’ thoughtful comments added further in- sight. Finally, IOM staff involvement and support throughout the process ensured a smooth and swift process from start to finish.

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